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FDA 510(k)

nextaro Transfer System, nextaro va

K-Number: K183187 · 2019-03-15

ApplicantSfm Medical Devices GmbH
Decision Date2019-03-15
Product CodeLHI
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

nextaro Transfer System, nextaro va is the device name listed in this FDA 510(k) record. The listed applicant is Sfm Medical Devices GmbH. It received FDA 510(k) clearance on 2019-03-15 under 510(k) number K183187. The device is classified under product code LHI. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the nextaro Transfer System, nextaro va?

nextaro Transfer System, nextaro va is a medical device that received FDA 510(k) clearance on 2019-03-15. The listed applicant is Sfm Medical Devices GmbH. The 510(k) number is K183187.

When did nextaro Transfer System, nextaro va receive FDA 510(k) clearance?

nextaro Transfer System, nextaro va received FDA 510(k) clearance on 2019-03-15, under 510(k) number K183187.

Who is the listed applicant for nextaro Transfer System, nextaro va?

The FDA 510(k) record lists Sfm Medical Devices GmbH as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for nextaro Transfer System, nextaro va?

The FDA product code for nextaro Transfer System, nextaro va is LHI.

Other records listing Sfm Medical Devices GmbH as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K241976nextaro® va, 15mm, 5µmK240748nextaro® v, 20/20

Related Devices (Code: LHI)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K252987ADRx™ Admixture DeviceEpic Medical Pte. , Ltd.K260301Vial AdapterHangzhou Qiantang Longyue Biotechnology Co., Ltd.K250345Medline Bag DecanterMedline Industries, LPK251715FlowArt® Vial Access Device VentedAsset MedikalK251676Medline Microtek C-Flo Bag Decanter, Sterile (2000S); Medline Microtek Bag Decanter II, Sterile (2002S); Medline Microtek Vial Decanter, Sterile (2006S); Medline Microtek Transfer Device, Sterile (2008S)Microtek Medical, LLCK243404HyHub™ and HyHub™ Duo Vial Access DevicesTakeda Pharmaceuticals

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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